Childrens Robitussin Honey Nighttime Cough DM

Product NDC: 0031-8762
11-digit product format: 000318762
Labeler code: 0031
Product ID: 0031-8762_350764de-7804-b24e-e063-6394a90ab3c3
Type: HUMAN OTC DRUG
Nonproprietary name: dextromethorphan hbr, doxylamine succinate
Dosage form: SOLUTION
Route: ORAL
Labeler: Haleon US Holdings LLC
Application: M012
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2019-05-27
Substance: DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength: 15; 6.25 mg/10mL; mg/10mL
Pharmacologic classes: Antihistamine [EPC], Histamine Receptor Antagonists [MoA], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Childrens Robitussin Honey Nighttime Cough DM
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	15 mg/10mL
DOXYLAMINE SUCCINATE	6.25 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
9D2RTI9KYH	Internal UNII lookup
V9BI9B5YI2	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1115329	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6afaf85b-bf0c-4c99-acf3-a34f06be20f1	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bf324df6-7127-7deb-def5-2681c136cd03	Product name	3	20250325
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
43a1ed49-eae2-4840-8075-cb4b33478540	Product name	1	20230425
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
ba088a92-ab5e-b2d4-e908-f5ea691b7587	Product name	7	20210201
f4368033-af8c-41bf-a84b-ff77392b8522	Product name	1	20161229
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
76633df9-0d59-4b88-03ed-21dee1b966f8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0031-8762-12	Childrens Robitussin Honey Nighttime Cough DM	118 mL in 1 BOTTLE	SOLUTION	118		11
0031-8762-12	Childrens Robitussin Honey Nighttime Cough DM	1 in 1 CARTON	SOLUTION	1		11
0031-8762-12	RobitussinChildrens Honey Day Night DM Value Pack	118 mL in 1 BOTTLE	SOLUTION	1 mL	15 mg in 10mL	2
0031-8762-12	RobitussinChildrens Honey Day Night DM Value Pack	1 in 1 CARTON	SOLUTION		6.25 mg in 10mL	2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0031-8762-12	ML - Milliliter	0031-8762	6760d42d-7a3c-47dd-9c2a-f30d8cec6e43	1	2025-12-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0031-8762	CHILDRENS ROBITUSSIN HONEY NIGHTTIME COUGH DM (DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE) SOLUTION [HALEON US HOLDINGS LLC]	11	Current NDC, Legacy NDC, 2 package rows	20250515_6afaf85b-bf0c-4c99-acf3-a34f06be20f1.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 153 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Alka-Seltzer Plus Severe Cold and Flu PowerFast Fizz	CHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE	Navajo Manufacturing Company Inc.	f6068011-ad56-59b4-e053-2995a90ac016	2024-10-03	Warnings	Exact identifier application number: M012
Benadryl Ultratabs	DIPHENHYDRAMINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	76433e3c-142c-4704-8b2b-d602f008c377	2024-10-02	Warnings	Exact identifier application number: M012
Afrin	OXYMETAZOLINE HYDROCHLORIDE	Navajo Manufacturing Company Inc.	65bf1556-f234-9439-e053-2a91aa0a3194	2024-10-02	Warnings	Exact identifier application number: M012
Nasal Decongestant	PSEUDOEPHEDRINE HCL	Proficient Rx LP	4eab4344-d95e-4b19-a21e-9c8ad033863a	2024-10-01	Warnings	Exact identifier application number: M012
pseudoephedrine hydrochloride	PSEUDOEPHEDRINE HCL	Proficient Rx LP	a910320b-0585-40bd-928c-0406346281d0	2024-10-01	Warnings	Exact identifier application number: M012
CareOne Nasal and Sinus Decongestant	PSEUDOEPHEDRINE HCL	American Sales Company	81b31070-9b03-4ce4-8aac-a334544842ae	2024-10-01	Warnings	Exact identifier application number: M012
Codeine-Guaifenesin	CODEINE PHOSPHATE AND GUAIFENESIN	Proficient Rx LP	20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d	2024-10-01	Warnings	Exact identifier application number: M012
meijer Nighttime Cold and Flu SOFTGEL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Meijer, Inc.	1bec5167-5fc5-2405-e063-6294a90a5358	2024-09-30	Warnings	Exact identifier application number: M012
good sense tussin dm	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	A-S Medication Solutions	19b3db33-86d1-48f3-9525-c7c87a4b6899	2024-09-29	Warnings	Exact identifier application number: M012
nasal decongestant maximum strength non drowsy	PSEUDOEPHEDRINE HCL	Meijer Distribution Inc	8a68ca99-fd76-409a-9769-88830e8720a8	2024-09-28	Warnings	Exact identifier application number: M012
good neighbor pharmacy tussin dm max	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Amerisource Bergen	58687394-b6d2-4d51-bde0-8f2cfa3fe909	2024-09-27	Warnings	Exact identifier application number: M012
good neighbor pharmacy nasal	OXYMETAZOLINE HYDROCHLORIDE	Amerisource Bergen	faee3aae-e819-4084-a127-3449be353b13	2024-09-27	Warnings	Exact identifier application number: M012
Tesalon Children	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAFEISIN USP, PHENYLEPHRINE HCL	OPMX LLC	2309620a-ccbc-41e9-e063-6394a90a9520	2024-09-26	Warnings	Exact identifier application number: M012
adult cough and chest congestion	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN	Meijer, Inc.	b11c4cee-bbb5-4585-9d38-6787553e13a0	2024-09-26	Warnings	Exact identifier application number: M012
COLD AND FLU NIGHTTIME SEVERE	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCL	TARGET CORP	9de9c34e-a0ca-cdf9-e053-2a95a90a93d3	2024-09-25	Warnings	Exact identifier application number: M012
Basic Care Daytime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL	Amazon.com Services LLC	8f3317f6-4ae8-474b-93c3-25e256519cb8	2024-09-25	Warnings	Exact identifier application number: M012
berkley and jensen tussin dm	DEXTROMETHORPHAN HBR, GUAIFENESIN	BJWC	b2de91c9-6af0-4881-8d2d-a69d90c8dfcd	2024-09-24	Warnings	Exact identifier application number: M012
Tussin DM Cough and Chest Non Drowsy	DEXTROMETHORPHAN HBR, GUAIFENESIN	WinCo Foods, LLC	13eb459c-3075-4038-8062-9ee7175b2ab9	2024-09-24	Warnings	Exact identifier application number: M012
equaline nasal decongestant non drowsy maximum strength	PSEUDOEPHEDRINE HCL	United Natural Foods, Inc. dba UNFI	8897580a-709a-4643-8264-ad003d90cbff	2024-09-22	Warnings	Exact identifier application number: M012
Chest Rub	CAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOL	Dabur India Limited	22916978-303d-e62a-e063-6394a90a2100	2024-09-20	Warnings	Exact identifier application number: M012

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
9D2RTI9KYH	DEXTROMETHORPHAN HYDROBROMIDE	6700-34-1	DEXTROMETHORPHAN HYDROBROMIDE
V9BI9B5YI2	DOXYLAMINE SUCCINATE	562-10-7	DOXYLAMINE SUCCINATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1115329	dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution	PSN	6afaf85b-bf0c-4c99-acf3-a34f06be20f1	11
1115329	dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution	SCD	6afaf85b-bf0c-4c99-acf3-a34f06be20f1	11
1115329	dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution	SY	6afaf85b-bf0c-4c99-acf3-a34f06be20f1	11
1115329	dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral Solution	SY	6afaf85b-bf0c-4c99-acf3-a34f06be20f1	11
2722413	{1 (dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral Solution) / 1 (dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution) } Pack	GPCK	f9999875-3433-4052-a628-39539d373216	2
2722413	1 daytime (dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral Solution) / 1 nighttime (dextromethorphan HBr 15 MG / doxylamine succinate 6.26 MG in 10 mL Oral Solution) Pack	PSN	f9999875-3433-4052-a628-39539d373216	2
1790650	dextromethorphan HBr 10 MG / guaiFENesin 100 MG in 10 mL Oral Solution	PSN	f9999875-3433-4052-a628-39539d373216	2
1115329	dextromethorphan HBr 30 MG / doxylamine succinate 12.5 MG in 20 mL Oral Solution	PSN	f9999875-3433-4052-a628-39539d373216	2
1790650	dextromethorphan hydrobromide 1 MG/ML / guaifenesin 10 MG/ML Oral Solution	SCD	f9999875-3433-4052-a628-39539d373216	2
1115329	dextromethorphan hydrobromide 1.5 MG/ML / doxylamine succinate 0.625 MG/ML Oral Solution	SCD	f9999875-3433-4052-a628-39539d373216	2
2722413	1 daytime (dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral Solution) / 1 nighttime (dextromethorphan HBr 15 MG / doxylamine succinate 6.26 MG per 10 ML Oral Solution) Pack	SY	f9999875-3433-4052-a628-39539d373216	2
1790650	dextromethorphan HBr 10 MG / guaifenesin 100 MG per 10 ML Oral Solution	SY	f9999875-3433-4052-a628-39539d373216	2
1790650	dextromethorphan HBr 20 MG / guaifenesin 200 MG per 20 ML Oral Solution	SY	f9999875-3433-4052-a628-39539d373216	2
1790650	dextromethorphan HBr 5 MG / guaifenesin 50 MG per 5 ML Oral Solution	SY	f9999875-3433-4052-a628-39539d373216	2
1115329	dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 20 ML Oral Solution	SY	f9999875-3433-4052-a628-39539d373216	2
1115329	dextromethorphan hydrobromide 7.5 MG / doxylamine succinate 3.125 MG per 5 ML Oral Solution	SY	f9999875-3433-4052-a628-39539d373216	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0031-8762-12	00031876212	1 BOTTLE in 1 CARTON (0031-8762-12) / 118 mL in 1 BOTTLE	1 bottle	2019-05-27	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	Haleon US Holdings LLC	2025-10-15	HUMAN OTC DRUG LABEL	2
Drug Facts	Haleon US Holdings LLC	2025-05-13	HUMAN OTC DRUG LABEL	11